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临床试验/NCT06303492
NCT06303492Unknown不适用

Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: a Multicentre Mixed Method Study- The ARGUMENT Study

Samuel Lunenfeld Research Institute, Mount Sinai Hospital0 个研究点目标入组 142 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
142
主要终点
Proportion of change in Anesthetic Plan

研究概览

简要总结

Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries.

详细描述

The proposed trial design is a mixed-method, multicenter study that includes a randomized controlled trial (RCT) and a qualitative assessment component. The RCT will evaluate the impact of adding GUS to the standard clinical assessment on the incidence of changes in the anesthetic plan for adult patients undergoing emergency surgery. The qualitative assessment will gather attending anesthesiologists' opinions on the addition of GUS in an emergency surgical setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • American Society of Anesthesiologists' (ASA) physical status I-III
  • Patients scheduled for non-elective non-cardiac surgery.

排除标准

  • Abnormal anatomy of the upper gastro-intestinal tract (including hiatus hernia, gastric tumors, and previous surgeries of the upper gastrointestinal tract).
  • Extrinsic gastric compression obtained from the medical history or during the actual ultrasound examination.
  • Pregnancy.
  • Attending anesthesiologist refusal to include the patient for participation in the study

研究组 & 干预措施

Gastric ultrasound (GUS) group

Experimental

Aspiration risk assessment using GUS in addition to the standard clinical assessment.

干预措施: GUS (Procedure)

Control

No Intervention

Aspiration risk assessment only by standard clinical assessment, and no GUS

结局指标

主要结局

Proportion of change in Anesthetic Plan

时间窗: Baseline

The primary outcome of the study is a change from the initial anesthetic plan after viewing GUS results in the intervention group, and after being given the opportunity to revise the plan in the control group.

次要结局

  • Percentage change in the three-category risk assessment before and after GUS(Baseline)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

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